Overview
Chagas’ disease, a serious and potentially fatal infection, is caused by Trypanosoma cruzi, a blood-borne parasite. Millions of people in Latin America carry the T. cruzi parasite and thus serve as a source of infection in the transfusion setting. Some experts estimate that there may be as many as 100,000 legal immigrants in the U.S. and Canada who are unknowingly infected with T. cruzi. Although only a few cases of blood transfusion or organ transplantation-transmitted cases have been reported in the U.S., it is well accepted that many other cases have occurred but have not been recognized, and donor screening questions have not been shown to successfully identify risk in U.S. blood donors. During past meetings of the Advisory Committee on Blood Safety and Availability, FDA has indicated that it would require testing for Chagas’ disease if a licensed test were to be available.

Recent Actions
1/18/07
AABB develops interim language on newly licensed test for Chagas' disease for Circulars of Information.

12/13/06
FDA announces that it has granted a license for a new test to screen blood donors for the parasite that causes Chagas’ disease. The screening test, Ortho T. cruzi ELISA Test System, detects the T. cruzi antibody in a sample of the donor’s serum or plasma and is the first such test approved by FDA. In addition to screening people who donate blood, this test is intended for use in screening plasma and serum samples from organ, cell and tissue donors.